L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML (NCT06788756)
A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L Annamycin for Injection in Combination With Cytarabine Injection Versus Placebo in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
This pivotal phase 2/3, multi-center, adaptive design study of L-Annamycin for Injection in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML is divided into two parts, Part A and Part B.
Who can join: Review the eligibility criteria below.
Location: University of Alabama Birmingham — Birmingham, Alabama
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (28 Sites)
Showing the first 25 of 28 sites.
- University of Alabama Birmingham — Birmingham, Alabama
- Bioresearch Partners — Miami, Florida
- Augusta University - Georgia Cancer Center — Augusta, Georgia
- University of Nebraska Medical Center — Omaha, Nebraska
- Atlantic Health — Morristown, New Jersey
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- University of Pennsylvania — Philadelphia, Pennsylvania
- University of Rhode Island — Providence, Rhode Island
- Fakultní nemocnice Hradec Králové — Hradec Králové,
- GEORGIA: LLC ARENSIA Exploratory Medicine — Tbilisi,
- Caucasus Medical Center — Tbilisi,
- RCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia — Bologna,
- AOU Careggi — Florence,
- AUSL della Romagna - Santa Maria delle Croci - Ravenna — Ravenna,
- Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart — Roma,
- LSMU Kauno klinikos — Kaunas,
- Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku — Olsztyn,
- Oddział Hematologii i Transplantacji Szpiku, Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan,
- Uniwersytecki Szpital Kliniczny Klinika Hematologii i Transplantologii (Szczecin) — Szczecin,
- Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddział Hematologii — Torun,
- Instytut Hematologii i Transfuzjologii, Klinika Hematologii — Warsaw,
- ARENSIA research clinic at the Oncology Institute "Prof. Dr. Ion Chiricuţă" — Cluj-Napoca,
- Institut Català d'Oncología (ICO) - Hospital Germans Trias i Pujol — Barcelona, Badalona
- Hospital Universitario Central de Asturias (HUCA) — Oviedo, Principality of Asturias
- Hospital MD Anderson Cancer Center Madrid — Madrid,
📞 Contact the Study Coordinator
Phone: (202) 760-1378
Email: pwaymack@moleculin.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Acute Myeloid Leukaemia (AML) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.